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Pain Pump Destroys Man’s Shoulder

Tuesday, August 20, 2013By ALG

By the Palo Alto Daily Post, and reprinted with its kind permission.

on-Q_pump_with_tags8A Mountain View man who said a simple shoulder surgery went seriously wrong when a device that provides intermittent pain medication was inserted into his joint has filed a lawsuit against the device’s maker, Palo Alto attorney Richard Alexander said yesterday.

Alexander said the “PainBuster On-Q Pain Pump” can destroy the cartilage within a joint when it is inserted for pain relief, a procedure that he claims was denied FDA approval, “not once, but twice.”

That’s what happened to Robert Moore, 38, after his doctor used a PainBuster following his surgery, Alexander said. “It completely destroyed all the cartilage in his shoulder, requiring a full shoulder replacement.

The lawsuit, which was filed in San Mateo County Superior Court because Moore was a resident of Redwood City at the time, said the device was manufactured and sold by I-Flow Corp. of Lake Forest. According to the suit, the device was originally approved by the FDA for use in muscle tissue, but not joints.

Alexander said the device was never approved for use within joints and that its maker knew of the kind of damage the pump could cause.

“What was supposed to be a simple procedure has left my client in need of a complete shoulder replacement,” Alexander told the Post. “And at this young age, he will be facing total shoulder replacements every 10 to 15 years. The worst aspect of this tragedy is that I-Flow kept this information to itself, knowing that its Pain Pump was being used contrary to FDA approval.”

Moore’s surgery was in 2007 and, according to Alexander, I-Flow changed the packaging for its device in fall 2006, “but never told surgeons to read the label for new safety information, or that the label had been changed.”

Alexander said that after the surgery, Moore began developing “severe pain” in the shoulder that had been operated on, and in May 2011, found out that he had shoulder chondrolysis – an irreversible destruction of cartilage.

Moore was a warehouse worker in Redwood City before losing the use of his shoulder. The lawsuit is seeking an undetermined amount of damages for injuries, mental suffering, lost income (past and future) and other noneconomic damages, which will be decided by the jury.

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